FDA product code · Dental

Point, Paper, Endodontic

Name: FDA decisions, review times, recalls and adverse event reports for product code EKN
Creator: 510(k) Report

EKNClass I21 CFR 872.3830510(k) exempt7 decisions since 19760 recalls

FDA lists EKN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 7 FDA decisions since 1976. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, dental panel

Twenty years of EKN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · EKN

FDA has decided no EKN device since 2007.

Median 510(k) review, days · EKN

Too few EKN 510(k)s in any year since 2007 to give a median.

Recalls per year · EKN

No recall names EKN since 2007.

Adverse event reports per year · EKN

No MAUDE report names EKN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — EKN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EKN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Point, Paper, Endodontic

What has FDA decided in EKN lately?